Derm News: 2006(2)

ALTANA Pharma - Press Release

NOVEL PESTICIDE-FREE TOPICAL HEAD LICE TREATMENT INTRODUCED AS MILLIONS OF CANADIAN KIDS RETURN TO SCHOOL

Fast-acting Resultz™ is highly effective, well tolerated and has distinct mechanism of action

Oakville, Ontario - August 28, 2006 - A unique pediculicide rinse called Resultz™ that has been shown to be 96 per cent effective in treating head lice is set to arrive in pharmacies across Canada in time for the new school year, offering health care professionals a new option with which to help parents eradicate this common condition. Highly effective when used as directed, Resultz does not contain pesticides, and does not have documented resistance problems associated with other medicated topical head lice treatments.

Existing topical treatments approved for use in Canada contain pesticides as their active ingredients, including pyrethrin, permethrin 1% and lindane, all of which have neurotoxic effects.2 One of these, lindane, was banned from future agricultural use by the Environmental Protection Agency in the United States just last month. Unlike these agents, Resultz has an entirely distinct mechanism of action. Resultz dissolves the wax that covers the exoskeleton of head lice, a mechanical mode of action that dehydrates lice and causes them to die. Resultz contains 50 per cent isopropyl myristate (active ingredient) and 50 per cent ST-cyclomethicone, ingredients commonly found in dermatologic preparations.

A recent Decima Research survey* of more than 1,000 Canadian parents found that nearly 70 per cent of those surveyed were unaware that most medicated head lice treatments contained pesticides, and more than nine out of 10 indicated they would prefer to use a treatment that was pesticide-free if it were as effective or more effective than currently available products.

"Head lice is common, and has a significant negative impact on children, parents and schools," says Denis Villeneuve, active member of the Canadian Pharmacists Association and Quebec Order of Pharmacists. "In addition to questions about pesticide use, treatment failure - whether due to improper use of the available products or potentially even caused by resistance - is also an issue. We need new options like Resultz that are effective and offer an alternative to pesticide-based products."

While formal studies to measure head lice resistance have not been performed in Canada, resistance to currently available pesticide-based treatments is an on-going global concern. Head lice resistance has been documented in countries as close as the United States, along with many other countries, including France, the United Kingdom, Czech Republic and Argentina.2 In some areas, resistance to some current treatments is as high as 80 per cent. Resistance is unlikely to develop with Resultz, due to its unique dehydrating mode of action.

Canadian-led study evaluated Resultz

A Canadian study1 presented at the 2005 American Academy of Dermatology meeting in New Orleans, evaluated Resultz for efficacy and safety. Twenty-nine of 30 subjects completed the study. Treatment was considered a success if two or fewer treatments over a 21-day period were required. The study showed 28/29, or 96 per cent, of the participants were lice-free after using Resultz. Among these subjects, there was a statistically significant reduction in the average head lice counts after treatment with Resultz. The difference between the pre-treatment and post-treatment final visits was dramatic (paired t-test p=0.0001).

One minute following treatment, lice were removed and evaluated for viability. All lice observed immediately after treatment under microscope were paralyzed and moribund, which led to 100 per cent confirmed mortality at the end of 24 hours. Four possible adverse events were reported during the trial, including scalp itch, irritation and erythema. Adverse events were infrequent and mild.1

"The level of success we documented with Resultz in this trial in achieving lice-free status definitely exceeded expectations," says Winnipeg-based Hill-Top Research scientist Dr. Nalini Kaul. "When you look at the efficacy, tolerability profile and simple dehydrating mode of action, it is clear that Resultz is an excellent choice for treating head lice. Health care professionals will also note the common dermatologic ingredients in Resultz, its fast-acting nature and ease of use."

Pediculosis perspective

One recent United Kingdom study found that nearly 40 per cent of children could get head lice in a given year; extrapolated to Canadian population figures, more than 1.5 million Canadian children could face head lice this year. Pharmacists particularly play a vital role in pediculosis education and counseling. In fact, a recent Decima Research survey* of more than 1,000 Canadian parents indicated that 65 per cent of parents consulted pharmacists either at the time of their child's lice infestation or their own. A total of 82 per cent consulted a health professional, including pharmacists, physicians or nurses, regarding a head lice infestation.

More on Resultz

Colorless and odorless, Resultz is easy to use. The first application takes 10 minutes (Day 1) and is repeated one week later (Day 7). After protecting the infested person's eyes with a towel, the product is applied to dry hair and scalp until the head and full length of hair are saturated and wet to touch. Once this application is complete, the product stays on the hair for 10 minutes and is rinsed away with warm water.

Distributed by ALTANA Pharma Inc. of Oakville, Ontario, Resultz can be purchased from pharmacies across Canada without a prescription in either 120 ml or 240 ml bottles. It is approved for use in persons aged four years and older.

About ALTANA

ALTANA Pharma adds value by improving the health of Canadians through people, innovative products and Canadian-based research in respirology, gastroenterology and dermatology. Designated as A Caring Company by Imagine Canada, ALTANA Pharma was named one of Canada's Top 100 Employers by Maclean's. Please visit www.altanapharma.ca. ALTANA Pharma Inc. is the Canadian pharmaceutical division of ALTANA AG (Germany).

*Note to Editor: Decima Research recently asked more than 1,000 Canadian parents of school-aged children about head lice through its proprietary online eVox panel. The results are considered accurate +/-3.1 per cent, 19 times out of 20.

™ Trademark of Piedmont Pharmaceuticals LLC, used under license by ALTANA Pharma Inc

Kaul, N. et al. In Vivo Efficacy and Safety of an Experimental Pediculicide Rinse. Poster presentation at 63rd Meeting of the American Academy of Dermatology, New Orleans, 2005.